Common use of Efficacy Assessments Clause in Contracts

Efficacy Assessments. The primary efficacy endpoint and many of the secondary and exploratory efficacy endpoints in this study are derived from clinician-administered assessments which must be administered by qualified and trained individuals at each clinical site. Study specific training will be required before staff is allowed to administer these scales. In an attempt to minimize variability in responses of a given patient over time, it is important that the same rater administer the scales to a given patient throughout the study unless absolutely unavoidable due to the rater’s absence from the clinic. It is also important that the assessments, including those that are patient-completed, be conducted in the specified order, according to specific instructions, and in a setting where the patient has minimal distractions, appropriate privacy, and sufficient time to complete them.

Efficacy Assessments. The primary efficacy endpoint and many of the secondary and exploratory efficacy endpoints in this study are derived from clinician-administered assessments which must be administered by qualified and trained individuals at each clinical site. Study specific training will be required before staff is allowed to administer these scales. In an attempt to minimize variability in responses of a given patient over time, it is important that the same rater administer the scales to a given patient throughout the study unless absolutely unavoidable due to the rater’s absence from the clinic. It is also important that the assessments, including those that are patient-patient- completed, be conducted in the specified order, according to specific instructions, and in a setting where the patient has minimal distractions, appropriate privacy, privacy and sufficient time to complete them.